The Recall Desk
ModerateFDA (Devices)·Z-1778-2022·Announced 2022-10-05

Incompatible tibial bearing supplied for knee prosthesis installation

An MK4 tibial bearing knee implant component was mistakenly supplied when an MK3 model was required. The mismatch was discovered during surgery and corrected by the surgeon.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall involving a device component mismatch discovered during surgery. No adverse events, injuries, or hospitalizations are mentioned in the source.

Plain-English summary

Howmedica Osteonics Corp. is recalling one MK4 Short Tibial Bearing (Catalog No. SMMLTB02, Lot B24694) distributed to a healthcare customer in New York. The device was supplied with the intent to be compatible with a Tibial Metal Casing but the patient's existing casing was an MK3 model. The MK4 bearing is not compatible with the MK3 casing and cannot be substituted for it.

The incompatibility was discovered during surgery. The surgeon removed the MK4 bearing and completed the procedure by re-assembling and re-inserting the patient's original MK3 tibial bearing.

This recall is issued to alert the healthcare provider and relevant parties to ensure proper device model verification during implant selection to prevent similar incidents.

The recalled product

Product
Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
Manufacturer
Howmedica Osteonics Corp.
Category
Medical Device — Orthopedic Implant
Hazard
  • device-incompatibility
  • supply-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot number B24694 (no UDI)

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category